Pharmaceuticals intended for oral administration are typically provided in solid form as tablets, capsules, pills, lozenges, or granules. Rapidly disintegrative tablets are often employed in the administration of pharmaceuticals where it is impractical to provide a tablet for swallowing whole, for instance with pediatric patients. Several workers in the field have explored rapidly disintegrative tablets (see, e.g., U.S. Pat. Nos. 6,106,861 and 6,024,981 and PCT Application No. WO 99/47126).
A dual portion dosage form that combines the use of a rapidly disintegrative tablet containing a pharmaceutically active agent with a slower disintegrative candy glass shell portion is disclosed. The dosage form provides both the benefit of the fast delivery of pharmaceutically active agent contained within the rapidly disintegrative tablet portion with the benefit of slower degrading candy glass shell portion, which may contain a second pharmaceutically active agent.
The dosage form of the invention can be used to treat, for example, a sore throat, which is characterized by a pain or irritation of the throat or pharynx, usually caused by acute pharyngitis. A sore throat is most often caused by a viral infection. A sore throat can also be caused by a streptococcal infection, tumors, gastroesophageal reflux disease, mononucleosis, and allergies.
A sore throat can develop for many reasons including a viral or bacterial infection, or a common or seasonal allergy. Often associated with an infection, common or seasonal allergy includes some degree of nasal or sinus congestion. This congestion is typically referred to as post-nasal drip, in which mucous originating on the surface of the nasal mucosa or the sinus mucosa drains onto the upper esophagus. The accumulation of nasal mucosa in the upper esophagus also stimulates the swallowing reflex often associated with a sore throat. The swallowing reflex transports the acidic mucous into relatively constant contact with the region of the throat. The acidic nature of the mucous from the sinus mucosa or nasal mucosa erodes the epithelial tissue of the throat thereby exposing the underlying tissue to the acidic mucous. The nerve endings in the underlying tissue in contact with the acidic mucosa cause what one identifies as the discomfort or pain associated with a sore throat. The more inflamed the nasal mucosa or the sinus mucosa, the greater the production of the acidic mucous, the greater the erosion and the greater the severity of the pain and discomfort associated with the sore throat.
The pain of sore throat can be treated with various dosage forms or remedies. Common dosage forms include throat sprays, lozenges, and orally administered tablets or liquids, all of which may contain active ingredients. Sprays and lozenges typically contain topical analgesics or menthol to cool the pain of a sore throat. Orally administered tablets or liquids typically contain systemically acting active ingredients for pain, cough and/or cold; including, e.g., acetaminophen, NSAIDs, decongestants, and/or cough suppressants. In some cases, these products contain sensates for cooling which also help in alleviating pain or providing the perception of alleviating pain.
One of the main disadvantages of such products is lack of immediate effect and/or short duration. In many cases, sprays or liquids do not provide extended pain relief because the composition is swallowed almost immediately upon ingestion.
There remains a need for compositions and methods that are safe and effective to treat, soothe or reduce the severity of a sore throat. Such a composition should work quickly and provide superior sore throat relief for an extended period of time.
U.S. Pat. No. 4,260,596 discloses an edible dosage form having an outer shell and a liquid or gel center which may contain a therapeutically effective amount of a medicament.
U.S. Pat. No. 4,517,205 discloses a co-deposited two-component hard candy having a hard candy shell portion and a core portion which may be soft, and method of making such candy.
U.S. Pat. No. 5,302,394 discloses a process for producing a dextromethorphan medicated hard candy lozenges on a continuous system.
U.S. Pat. Nos. 5,549,906; 5,662,920; and 6,280,761 disclose a nicotine lozenge for smoking cessation.
U.S. Pat. No. 5,614,207 discloses a dry mouth lozenge that comprises a lozenge base, a demulcent, a humectant, and a pharmaceutically acceptable acidulent to stimulate the flow of saliva.
U.S. Pat. No. 5,616,340 discloses a hard-candy based lozenge containing an antacid that is produced in a manner compatible with a continuous process method of manufacture.
U.S. Pat. No. 5,871,781 discloses an apparatus for making comestible units that can include active ingredients and are capable of dissolving in the mouth within several seconds.
U.S. Published Application No. 20050019376 discloses a dosage form that comprises at least one active ingredient, a confectionery composition and at least one face, wherein the relative standard deviation of the weight of the dosage form is less than 1%.
U.S. Published Application No. 20050142199 discloses a pharmaceutical dosage form that comprises a tablet core comprising a pharmaceutically active ingredient and a coating extending over at least 25% of the surface area of the tablet core, the coating resulting from deposition of a powder comprising fusible particles and fusing the particles to form a coating film.
U.S. Published Application No. 20050238695 discloses an organoleptically pleasing lozenge.
U.S. Published Application No. 20070087053 discloses a multi-component composition for the treatment of dry mouth that comprises a first part that rapidly disintegrates in the oral cavity and releases a sialogogic compound, in combination with an effervescent organic acid-based buffering system and a second part that releases a demulcent compound into the oral cavity over a period of several minutes.
U.S. Published Application No. 2008286340 discloses an oral formulation that comprises nicotine and at least one amino acid in an amount effective to buffer the formulation.
U.S. Published Application No. 20090004248 discloses a dosage form including both a disintegrative tablet portion and a hard candy portion, wherein: (i) the disintegrative tablet portion comprises at least one pharmaceutically active agent, and (ii) the hard candy portion covers at least 20% of the surface of the disintegrative tablet portion, and wherein the disintegration time of the hard candy portion is at least ten times longer than the disintegration time of the disintegrative tablet portion. The reference discloses preparation of a dosage form that contains a hard candy portion and a disintegrative tablet portion that includes placing a compressed tablet in a mold that covers the faces of the tablet and injecting a flowable hard candy blend to surround the circumference of the tablet. The reference also discloses preparation of a dosage form that contains two layers that includes placing a compressed tablet on a flat face of a surface of a hard candy that contains PEG 3350; and heating the resulting dosage form such that the PEG 3350 melts and creates adhesion between the surfaces of the tablet and the hard candy.
U.S. Published Application No. 20090011079 discloses a hard-coated confectionary product having a consumable, soft, fortified, high solids and chewy core encapsulated in a hard-consumable coating and a method for making the fortified confectionary.
U.S. Published Application No. 20100124560 discloses a multi portion intra-oral dosage form where at least one portion is rapidly disintegrating and at least one portion is slowly disintegrating, whereby the disintegration time for the slowest disintegrating portion is at least two times longer than for the most rapidly disintegrating portion. The reference discloses preparation of a dual portion dosage form that includes compressing two portions of blended material into tablets by means of direct compression. The reference also discloses preparation of a dual portion dosage form that includes dispensing a melt tablet portion on top of a cooled candy portion.
U.S. Published Applications Nos. WO2013103318 and 20160095818 disclose pharmaceutical dosage forms that comprise a core coated by at least one film coating. The core comprises at least one API, wherein one or more organoleptically disturbing sensations of the active pharmaceutical ingredient (API) are reduced by constituents of the film coating.
U.S. Pat. No. 8,865,204 discloses a lozenge prepared by a process that includes forming a powder blend containing an amorphous carbohydrate polymer into a desired shape and applying radiofrequency energy to the shape for a sufficient period of time to soften or melt the amorphous carbohydrate polymer to fuse the shape into a lozenge product.
There remains a need to produce a lozenge dosage form and an efficient, commercially feasible method of producing such dosage form.
An objective of this invention is to provide an efficient method of producing a two-component dosage form which is readily adaptable to commercial production.
A dosage form can be made, at a commercial production level, having a core portion which is distinctive from the shell portion in function, and, if desired, in texture, flavor, and optical characteristics such as color and light transmission. Moreover, the present invention enables practitioners to conveniently include an active ingredient in an attractive, organoleptically-pleasing, hard candy confection.